Global Program Regulatory Manager

Basel  ‐ Onsite
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Description

Global Program Regulatory Manager wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:
  • Excellent knowledge of regulatory submission and approval processes as well as portfolio brand management
  • Proficiency in terms of product licenses, especially regarding preparation of documents for EU license renewals
  • Expertise in HA negotiations as well as a solid understanding of post-marketing / brand optimization strategies and commercial awareness
  • Languages: fluent English both written and spoken


Your tasks:
  • Maintaining product licenses world-wide for assigned products as well as preparing IND/NDA Annual Reports and DSURs
  • Operationally executing specific regulatory deliverables relating to world-wide maintenance, upkeep and lifecycle management of assigned global portfolio brands
  • Preparing all necessary supporting documentation for EU license renewals, EU variations and PSUR submissions
  • Addressing HA requests and leading preparation of HA responses
  • Managing interactions with RA colleagues in CPOs and participating in regulatory subteams; preparation of IND/NDA Annual Reports & DSURs


Start: ASAP
Duration: 6MM+
Location: Basel, Switzerland
Ref.Nr.: BH12934

Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.

Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

Going the extra mile…

New to Switzerland? In case of successful placement, we support you with:
  • All administrative questions
  • Finding an apartment
  • Health - and social insurance


Work permit and much more
Start date
06/2018
From
RM Group
Published at
21.06.2018
Project ID:
1580474
Contract type
Freelance
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